Once considered completely out of bounds for scientific research, there’s a renewed sense of hope surrounding cannabis with the DEA finally granting new licenses for several companies to produce marijuana for research purposes.
One of those companies is Royal Emerald Pharmaceuticals, based in Desert Hot Springs, California, which now has four licenses allowing it to research, develop and manufacture drugs derived from cannabis and other botanicals. The company’s two most recent licenses — for bulk manufacturing and import — were granted on December 2, 2021, clearing the way for the first seeds to be planted.
Royal Emerald is nearing completion of Phase 1 of its 100,000-square-foot production facility that will supply researchers and universities across the country with high-quality cannabis that has long been unavailable to any federally funded research organizations. The company is also aiming to create products specifically for veterans, law enforcement and first responders who commonly suffer from myriad ailments, including post-traumatic stress disorder, opioid addiction, anxiety and depression.
Marijuana Venture spoke with chief operating officer Justin Abril about Royal Pharmaceuticals’ veteran-focused approach, the challenge of being regulated by the U.S. Food and Drug Administration and the future of pharmaceutical-grade cannabis.
Marijuana Venture: What’s the story of Royal Emerald Pharmaceuticals, prior to receiving these licenses?
Justin Abril: I met (Royal Emerald Pharmaceuticals founder and CEO) Mark Crozier when we were federal law enforcement officers for the Department of Defense about 12 years ago.
Our careers took us on different paths, but we’ve always been working with military personnel, veterans, first responders, law enforcement, EMTs and firefighters. And what we noticed was that the tribulations that a lot of us faced, whether it was PTSD, chronic pain or other ailments, were very detrimental to those communities. And then when we looked at the over-prescription of opiates, that exacerbated a lot of those problems — 80% of the calls we were responding to were related to either substance abuse and/or mental health.
Being in state-legal markets, a lot of people were seeking relief for chronic pain and PTSD through cannabis and its constituents. But there still wasn’t proper FDA research done on cannabis, on its safety and efficacy, for patients seeking relief from those conditions. And that’s where we started Royal Emerald.
With our backgrounds in government and law enforcement, we knew the Feds were very interested in cannabis, especially five or six years ago.
So we’ve been working closely with the DEA for the last three or four years to get the proper licensing to cultivate cannabis for federal research. We’ve invested a lot of money into a state-of-the-art facility to ensure that what we produce here at our facility can further the research that not only the U.S. government wants to conduct, but also third-party researchers like universities and other drug developers. It’s really bringing the United States up to par with the rest of the world as far as research that’s been conducted for many years now.
MV: What does the next six months or so look like for Royal Emerald Pharmaceuticals, now that the licensing process has been completed?
JA: Over the next six months, we want to finally finish Phase 1 of our facility, which is about 60,000 square feet of cultivation and manufacturing space. And all of the cannabis we grow will be sold back to the government to be distributed among researchers across the United States.
We are really trying to correct the supply chain issue that has stunted research over the past 10 to 15 years, because there hasn’t been suitable pharmaceutical-grade cannabis for research. The University of Mississippi has held this exclusive license since 1968 and what they have been producing for the past 50-plus years hasn’t been sufficient. We want to gain that confidence back and support a lot of the research that will further the development of cannabis.
MV: There have been plenty of pictures and reports about the low quality of marijuana coming out of the University of Mississippi. How do you ensure the crop being produced at Royal Emerald is in line with what researchers need and what consumers are ultimately looking for?
JA: We’ve taken a long time to connect and consult with leading experts in the field when it comes to cannabis cultivation and growing high-quality cannabis indoors. We spent years designing this facility to ensure it meets those strict standards that the FDA puts in place, so everything we put into this facility is highly controlled and highly isolated to mitigate any potential for contamination.
MV: Have you hired a head grower or a horticulturist to oversee the cultivation side?
JA: It’s on the to do list. We’re working with several experts. They’ve been helping us design our facility to ensure that we meet those conditions and requirements. We’re looking to hire a master grower to learn under the people we’re collaborating with to ensure they’re implementing all the policies and procedures that we’re putting in place here at the facility.
We’re hoping to find a grower that has been working with cannabis for at least five to 10 years, but not to that level where they’re very set in their ways. We need someone that’s still open to learn and open to understand a lot of those gaps we’re trying to bridge to bring cannabis up to a pharmaceutical level.
MV: There are a lot of people in cannabis, both on the consumer side and within the industry, that are concerned about pharmaceutical companies getting into the cannabis space. They’re worried that Big Pharma will try to monopolize the industry or take the big business approach to health care that has been detrimental to so many people. How would you respond to these concerns?
JA: When I came on this project, what really drove my passion was having a chance to make a big difference in people’s lives. We’re past the proof of concept; we know cannabis can help people in certain forms and in certain ways.
I think we have to learn to work together with the state markets and be in this together. I don’t think us coming in or Big Pharma coming in is going to manipulate and change the market. The recreational markets will coexist with what we’re developing; what we’re trying to produce is for those who are really seeking proper therapeutic relief from the conditions they’re facing.
We want a patient to be able to be comfortable going to their doctor, knowing what they’re getting prescribed is safe, effective and can be used with other medications, and that their insurance can cover it. By no means do I think this would destroy or disrupt the recreational market.
If a consumer doesn’t want or need to go that route, then they have the recreational markets that they can go to and continue to seek help.
MV: How many employees does Royal Emerald have right now and what does the ramp-up look like over the next year?
JA: Currently, we have about 16 employees. We’re a very small staff right now, just to get to the point we’re at. Once Phase 1 of the facility is complete, that will be about 60% of our cultivation and manufacturing space and we will need to hire at least 120 employees. That should be complete by April.
And by the end of 2022, the rest of the facility should be built out and that should ramp us up to about 160 to 200 employees.
MV: How does Royal Emerald’s facility and equipment compare with your standard commercial cannabis production facility in California?
MV: Our facility is going to be registered and inspected by the FDA, so we have to meet not just certain food requirements, but also the pharmaceutical requirements with highly clean, GMP manufacturing areas. When you come to our facility, cleanliness is the utmost priority.
On top of that, the DEA has specific requirements when it comes to security. I can’t disclose too much of the details of that, but imagine a highly secure federal facility. If an employee who worked in a commercial, recreational grow came to our facility, they would be greatly surprised by the security measures.
MV: You’ve talked about developing products for veterans, in particular. Why have you chosen that approach, targeting a specific demographic, as opposed to a specific condition, such as PTSD?
JA: Our passions and our experiences, in most of our careers, have been with veterans, with law enforcement and with first responders. Across the board, these demographics always seems to have the same underlying conditions of PTSD, stemming from chronic pain and other mental health disorders all accumulated together.
And we always felt like those populations are greatly underserved and over-prescribed — especially the veterans population. We are targeting those therapeutic conditions, but we want to do it in partnership and prioritizing those demographics. We also know there is already government funding and government contracts specifically for those demographics, when it comes to those therapeutic conditions, so it all just aligns perfectly. Who doesn’t want to be part of something that’s going to help those who sacrificed so much to help not just our local communities, but our country as well?
MV: Is it weird for you to come from a law enforcement background that has historically looked at cannabis use and possession as a crime to now be in a space where it’s semi-legal and supported by the U.S. government?
JA: Yeah, a lot of my former co-workers are still shocked when I tell them what I’m doing now. But I think, even among the law enforcement community, the stigma surrounding marijuana or cannabis has changed greatly. Even before I got into this industry, I knew there was something there and knew there was a lot of potential, but unfortunately, with how our laws are structured, we had to do what we had to do when it came to the enforcement of controlled substances.
The only regret I have is that I personally knew several instances where military members’ careers were ruined because of their cannabis use. Looking back, they were only seeking relief; they were only trying to get off of opiates, the stuff that was actually damaging their lives. And their careers were ruined over it. I don’t want to see that anymore. And I want them to have a product that they can feel comfortable getting, without risking their careers, risking the retirements or anything like that.
So, yeah, it’s weird coming from a law enforcement background, but I know that it’s for a bigger, better purpose.
MV: What was the moment like when you found out Royal Emerald had finally received its DEA licenses?
JA: It was very anticlimactic when we finally got the license, especially after building it out for three, almost four years. We’re just very excited to push this forward and happy to start this new year on this mission to help veterans and first responders and ultimately the rest of the country to benefit from this, once we get some FDA-approved medications out there for commercial distribution.
Once we got the license, it was like, “Hey, now it’s time to work. Now it’s time to execute.”
This interview was edited for length and clarity.